Search Results for medical countermeasures

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FDA Drafts PRV Guidance for Medical Countermeasures By Zachary Brennan - Published 17 January 2018

The US Food and Drug Administration (FDA) on Wednesday released new draft guidance to help companies understand how the agency will award priority review vouchers (PRVs) for qualifying medical products to diagnose, prevent or treat diseases or conditions associated with chemical, biological, radiological and nuclear (CBRN) threats and emerging infectious diseases.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: priority review voucher, PRV, medical countermeasures

How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs By Zachary Brennan - Published 15 August 2017

As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: priority review vouchers, biodefense, medical countermeasures

FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles By Michael Mezher - Published 24 April 2017

In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline.

Categories: News, US, FDA, Drugs

Tags: Doxycycline, Medical Countermeasures, MCM, Anthrax

FDA Offers 2016 Report on Medical Countermeasure Activities By Zachary Brennan - Published 20 March 2017

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality

Tags: medical countermeasures, Ebola, Zika, flu vaccine

Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue By Zachary Brennan - Published 25 August 2016

Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology, Clinical, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: Animal Rule, Nature, Accelerated Approval, Ebola, Anthrax, medical countermeasures

European Regulatory Roundup: Germany Joins EU Medical Countermeasure Procurement Alliance (21 April 2016) By Nick Paul Taylor - Published 21 April 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs

Tags: European Regulatory Roundup, PRAC, medical countermeasures, Gilead, Sovaldi, Harvoni

Congress Considers Priority Review Vouchers for Medical Countermeasures By Michael Mezher - Published 12 February 2016

Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats.

Categories: News, Latin America and Caribbean, US, FDA, Biologics and biotechnology, In vitro diagnostics, Regulatory strategy, Research and development, Submission and registration

Tags: Biodefense, Blue Ribbon Study Panel on Biodefense, Medical Countermeasures, MCMs, Priority Review Voucher, PRV, Zika Virus, Ebola, Bioterrorism

Sentinel, iPod-Based Devices can Match Patients to EHRs in Public Health Emergencies By Michael Mezher - Published 05 February 2016

A recent study funded by the US Food and Drug Administration (FDA) found that an iPod Touch-based platform and FDA's Sentinel system could be used to accurately track the safety of drugs and vaccines dispensed during public health emergencies.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: Electronic health records, EHR, Sentinel, Mini-Sentinel, Medical Countermeasures, MCM

Senators Propose New Exclusivity Voucher, Priority Review Voucher Programs By Zachary Brennan - Published 22 October 2015

Senators on both sides of the aisle are trying to incentivize the development of new drugs for newborn babies and medical countermeasures via a new exclusivity voucher and a priority review voucher system that are similar to the voucher programs already linked to tropical and rare pediatric disease treatments.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Submission and registration

Tags: priority review voucher programs, PRV, pediatric disease, neonatal drug development, medical countermeasures, Senator Bob Casey

Are Medical Countermeasures Meeting the Potential Needs of Children? By Alexander Gaffney, RF News Editor - Published 01 May 2013

Categories: US, FDA

Tags: MCM, Medical Countermeasures, Children, Pediatric, Report, Latest News, GAO, DHHS

Changes Needed to Allow Pediatric Testing of Medical Countermeasures, Report Says By Alexander Gaffney, RF News Editor - Published 19 March 2013

Tags: MCM, Medical Countermeasures, Bioethics

Presidential Commission Looking to Study Ethical Issues of Animal Rule in Pediatric Populations By Alexander Gaffney - Published 28 June 2012

Tags: Medical Countermeasures, Bioethics, Children, Pediatric, Animal Rule, Latest News, testing

FDA's Chief Scientist Reveals Planned Animal Rule Revisions, Regulatory Science Initiatives By Alexander Gaffney - Published 03 May 2012

Categories: FDA

Tags: MCMi, Medical Countermeasures, Science Board, Presentation, Goodman, Bioeconomy, Latest News, regulatory science, regulatory